CCI-779 in Treating Patients With Soft Tissue Sarcoma or Gastrointestinal Stromal Tumor
Gastrointestinal Stromal Tumor, Recurrent Adult Soft Tissue Sarcoma, Stage I Adult Soft Tissue Sarcoma
About this trial
This is an interventional treatment trial for Gastrointestinal Stromal Tumor
Eligibility Criteria
Inclusion Criteria: Histologically or cytologic confirmed soft tissue sarcoma Measurable disease; for patients having only lesions measuring at least 1 cm to less than 2 cm, must use spiral CT imaging for both pre- and post-treatment tumor assessments Absolute neutrophil count (ANC) >= 1,500/μL Platelets (PLTS) >= 100,000/μL Hgb >= 10.0 g/dL Direct bilirubin =< 1.5 x ULN (upper limit normal) AST(SGOT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present ALT(SGPT) =< 2.5 x ULN or =< 5 x ULN* if liver metastases are present Creatinine =< 1.5 x ULN, or if greater, creatinine clearance >= 50 mL/min/1.73 m^2 Baseline glucose levels Fasting serum cholesterol =< 350 mg/dL (9.0 mmol/L) Fasting triglycerides =< 400 mg/dL (4.56 mmol/L) ECOG Performance Status (PS) 0, 1 or 2 Life expectancy >= 12 weeks Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent Exclusion Criteria: Any of the following as this regimen may be harmful to a developing fetus or nursing child: Pregnant women Breast-feeding women Men or women of childbearing potential or their sexual partners who are unwilling to employ adequate contraception ( diaphragm, birth control pills, injections, intrauterine device [IUD], surgical sterilization, subcutaneous implants, or abstinence, etc.) Any of the following: Nitrosoureas or mitomycin =< 6 weeks prior to study entry Other chemotherapy =< 4 weeks prior to study entry Radiotherapy =< 4 weeks prior to study entry Concurrent use of any other investigation agent Adverse events due to agents administered =< 4 weeks prior to study entry History of allergic reactions attributed to compounds of similar chemical or biologic composition to CCI-779 Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, diabetes, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Known HIV-positive patients receiving combination anti-retroviral therapy Prior chemotherapy for metastatic disease Exceptions: Patients with GIST who fail Gleevec are eligible Patients who have had adjuvant/neoadjuvant chemotherapy are also eligible Known brain metastases Exception: Patients with treated brain metastatic disease with stable symptoms after treatment for >= 1 month
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Experimental
Treatment (temsirolimus)
Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.